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Job Details

Associate Director Regulatory Strategy

Company: EPM Scientific
Location: Boston
Reference: MLSN112917622
Closing Date: 13 Dec 17
Type: Permanent
Salary (£): 100,000+
Benefits:

Job Summary:

Position Summary:A leading biopharmaceutical company focuses on high unmet medical needs is looking for an Associate Director, Regulatory Strategy to join a newly opened...

Requirements:

Position Summary:


A leading biopharmaceutical company focuses on high unmet medical needs is looking for an Associate Director, Regulatory Strategy to join a newly opened role.

 
The Associate Director, Regulatory Affairs will be responsible for developing and implementing regulatory strategy This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for global programs. 

 

Responsibilities:

  • Serve as global regulatory team leader on assigned programs.
  • Provides advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues within (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
  • Prepares and executes aspects of US regulatory affairs, and ensures integration into global regulatory strategy.
  • Represents as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development.
  • Coordinates submissions to FDA in support of proposed and ongoing development programs, e.g., new IND submissions, IND amendments, etc. 

Qualifications:

  • Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
  • Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
  • intra-team relationships and collaborate in a global team environment at all levels of the organization.
  • Strong interpersonal, and written/verbal communication skills.
  • Proven track record practicing sound judgment as it relates to risk assessment
  • Highly conversant and knowledgeable of new and emerging regulations and guidances. 

Apply for this job: Associate Director Regulatory Strategy

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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